Comparing tear structure in menopausal and non-menopausal women
Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)
This study is testing how menopause affects tear quality and production in women, including those on hormone therapy, to see if there are differences between pre-menopausal and post-menopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | Female |
| Sponsor | Chung Shan Medical University Academic / other |
| Locations | 1 site (Taichung, Taiwan) |
| Trial ID | NCT06848829 on ClinicalTrials.gov |
What this trial studies
This study analyzes the differences in tear ferning patterns between pre-menopausal and post-menopausal women, including those receiving hormone replacement therapy. It involves collecting tear and blood samples to perform an enzyme-linked immunosorbent assay related to menopause. Additionally, measurements of tear volume, osmolarity, intraocular pressure, and tear break-up time are conducted to assess dry eye conditions. The goal is to better understand how menopause affects tear production and quality.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 65, both pre-menopausal and post-menopausal.
Not a fit: Patients with existing ocular diseases or those in vulnerable groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for dry eye syndromes in menopausal women.
How similar studies have performed: While there is limited data on this specific approach, studies on tear ferning and menopause have shown promising results in understanding dry eye conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 20 and 65 years Exclusion Criteria: * No evident ocular diseases such as cornea, cataracts, vitreous degeneration, glaucoma, and retinopathy. * Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
Where this trial is running
Taichung, Taiwan
- Jen-Ai Hospital — Taichung, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: David P Lin, PhD
- Email: pcl@csmu.edu.tw
- Phone: 886-910-371286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.